FDA-Drug2023-05-10Class II
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
PD-Rx Pharmaceuticals, Inc.
Hazard
CGMP deviations.
Sold states
Nationwide in the US.
Affected count
352 bottles
Manufactured in
727 N Ann Arbor Ave, Oklahoma City, OK, United States
Products
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0557-2023Don't want to check this manually?
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